Policies & Legislation

The Health Ministry in Quebec, Canada is launching a tender process for generics in an attempt to save millions of dollars. It is hoped that the new system will make medication cheaper for patients and save taxpayers CA$300 million per year.

The European Medicines Agency (EMA) announced that it will launch a ‘new and improved version of EudraVigilance’ in November 2017, which will contain enhancements for reporting and analysing suspected adverse reactions.

In a landmark decision by the US Supreme Court, biosimilars makers will be able to give notice to the originator manufacturer before the US Food and Drug Administration (FDA) has given final approval of the biosimilar.

The Association for Accessible Medicines (AAM) has recommended five changes to US Food and Drug Administration (FDA) regulation, including allowing abbreviated new drug application (ANDA) sponsors the same rights as those for non-generic drugs.

Senator Pat Roberts and Representatives Joe Barton and Anna Eshoo, along with a delegation of 52 House Members and nine Senators, have asked the Centers for Medicare & Medicaid Services (CMS) to reverse its biosimilars policy.

The Fair Access Safety and Timely Generics Act has been reintroduced to congress, promising to save the US billions of dollars each year, while California has introduced a bill that would ban the use of coupons for prescription drugs where a cheaper alternative exists.

On 26 April 2017, the US Supreme Court heard oral arguments in Amgen vs Sandoz. The case has come to the Supreme Court after the Court of Appeals for the Federal Circuit made the controversial ruling that the so-called ‘patent dance’ was optional, but also that the 180-day notice could only be given after the 12-year exclusivity period ended.

The US Food and Drug Administration (FDA) announced on 2 March 2017 that the state of Maryland General Assembly was considering two bills that would require pharmaceutical companies to notify the state ahead of drug price increases. On 20 March 2017, one of these bills that sets out to ban excessive price increases for generics and off-patent drugs, was passed. In the US, legislation related to pharmaceuticals can vary across states [1].

The UK’s Competition and Markets Authority (CMA) alleged that pharmaceutical companies, Actavis UK and Concordia, entered into illegal agreements that allowed them to increase and maintain high prices of hydrocortisone tablets.